CN112512513A - 用于延缓活性物质在远端结肠中释放的具有多层结构的丸剂 - Google Patents

用于延缓活性物质在远端结肠中释放的具有多层结构的丸剂 Download PDF

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Publication number
CN112512513A
CN112512513A CN201980049484.XA CN201980049484A CN112512513A CN 112512513 A CN112512513 A CN 112512513A CN 201980049484 A CN201980049484 A CN 201980049484A CN 112512513 A CN112512513 A CN 112512513A
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CN
China
Prior art keywords
active substance
budesonide
release
pellets
layer
Prior art date
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Pending
Application number
CN201980049484.XA
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English (en)
Chinese (zh)
Inventor
R.威廉
M.普罗尔斯
R.格雷恩沃德
T.纳卡克
A.博格肖森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dr Falk Pharma GmbH
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Dr Falk Pharma GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dr Falk Pharma GmbH filed Critical Dr Falk Pharma GmbH
Publication of CN112512513A publication Critical patent/CN112512513A/zh
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009Sachets, pouches characterised by the material or function of the envelope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN201980049484.XA 2018-08-24 2019-08-22 用于延缓活性物质在远端结肠中释放的具有多层结构的丸剂 Pending CN112512513A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18190638.9 2018-08-24
EP18190638.9A EP3613414A1 (de) 2018-08-24 2018-08-24 Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon
PCT/EP2019/072429 WO2020039017A1 (de) 2018-08-24 2019-08-22 Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon

Publications (1)

Publication Number Publication Date
CN112512513A true CN112512513A (zh) 2021-03-16

Family

ID=63405023

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201980049484.XA Pending CN112512513A (zh) 2018-08-24 2019-08-22 用于延缓活性物质在远端结肠中释放的具有多层结构的丸剂

Country Status (20)

Country Link
US (1) US11173121B2 (hr)
EP (2) EP3613414A1 (hr)
JP (1) JP7374992B2 (hr)
CN (1) CN112512513A (hr)
AU (1) AU2019326752A1 (hr)
CA (1) CA3108257A1 (hr)
DK (1) DK3840734T3 (hr)
EA (1) EA202190565A1 (hr)
ES (1) ES2927000T3 (hr)
HR (1) HRP20221162T1 (hr)
HU (1) HUE060169T2 (hr)
IL (1) IL279825B2 (hr)
LT (1) LT3840734T (hr)
PL (1) PL3840734T3 (hr)
PT (1) PT3840734T (hr)
RS (1) RS63628B1 (hr)
SI (1) SI3840734T1 (hr)
UA (1) UA127521C2 (hr)
WO (1) WO2020039017A1 (hr)
ZA (1) ZA202100512B (hr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4382099A1 (en) 2022-12-05 2024-06-12 ADD Advanced Drug Delivery Technologies, Ltd. Drug loaded modified release pellets

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5932249A (en) * 1993-09-23 1999-08-03 Dr. Falk Pharma Gmbh Budesonide pellets with a controlled released pattern and process for producing the same
US20050089571A1 (en) * 2002-03-27 2005-04-28 Roehm Gmbh & Co.Kg Pharmaceutical formulation for the active ingredient budesonide
EP1607087A1 (en) * 2003-03-27 2005-12-21 Hisamitsu Pharmaceutical Co., Inc. Medicinal oral preparations for colon delivery, medicinal oral preparations for treating colon cancer and medicinal oral preparations for treating colitis
CN101108171A (zh) * 2006-07-17 2008-01-23 复旦大学 一种布地奈德肠溶缓释微丸及其制备方法
CN101677958A (zh) * 2007-03-26 2010-03-24 帝国制药株式会社 用于结肠-特异性递送的口服药物制剂

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE8903914D0 (sv) 1989-11-22 1989-11-22 Draco Ab Oral composition for the treatment of inflammatory bowel diseases
US5643602A (en) * 1989-11-22 1997-07-01 Astra Aktiebolag Oral composition for the treatment of inflammatory bowel disease
DE4340057A1 (de) * 1993-11-24 1995-06-01 Falk Pharma Gmbh Budesonid-Arzneimittel zur Verbesserung der enteralen Flüssigkeitsresorption, insbesondere nach postoperativen Zuständen
PT1183014E (pt) 1999-06-14 2003-12-31 Cosmo Spa Composicoes farmaceuticas orais de libertacao controlada e de dissimulacao de sabor
JP2004507487A (ja) 2000-08-29 2004-03-11 メファ・アクチェンゲゼルシャフト 腸疾患治療薬
MXPA04004747A (es) 2001-11-23 2004-08-02 Procter & Gamble Forma de dosificacion farmaceutica con multiples recubrimientos.
DE10250543A1 (de) * 2002-10-29 2004-05-19 Röhm GmbH & Co. KG Mehrschichtige Arzneiform
DE602004028497D1 (de) * 2003-09-15 2010-09-16 Nycomed Gmbh Verwendung von ciclesonid zur behandlung von entzündlichen darmerkrankungen
GB0808537D0 (en) 2008-05-12 2008-06-18 Archimedes Dev Ltd Compositions
CN103705481B (zh) 2013-11-15 2017-10-20 中国药科大学 一种萘普生结肠定位释药微丸及其制备方法
EP3346996A4 (en) * 2015-09-11 2019-04-17 Sun Pharmaceutical Industries Limited ORAL PHARMACEUTICAL PHARMACEUTICAL FORM OF BUDESONID
EP3257501A1 (en) 2016-06-14 2017-12-20 Tillotts Pharma AG Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material, and an enteric core coating

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5932249A (en) * 1993-09-23 1999-08-03 Dr. Falk Pharma Gmbh Budesonide pellets with a controlled released pattern and process for producing the same
US20050089571A1 (en) * 2002-03-27 2005-04-28 Roehm Gmbh & Co.Kg Pharmaceutical formulation for the active ingredient budesonide
EP1607087A1 (en) * 2003-03-27 2005-12-21 Hisamitsu Pharmaceutical Co., Inc. Medicinal oral preparations for colon delivery, medicinal oral preparations for treating colon cancer and medicinal oral preparations for treating colitis
CN101108171A (zh) * 2006-07-17 2008-01-23 复旦大学 一种布地奈德肠溶缓释微丸及其制备方法
CN101677958A (zh) * 2007-03-26 2010-03-24 帝国制药株式会社 用于结肠-特异性递送的口服药物制剂

Also Published As

Publication number Publication date
UA127521C2 (uk) 2023-09-20
US20210228487A1 (en) 2021-07-29
CA3108257A1 (en) 2020-02-27
LT3840734T (lt) 2022-10-25
EP3613414A1 (de) 2020-02-26
AU2019326752A1 (en) 2021-01-28
EA202190565A1 (ru) 2021-06-01
IL279825B2 (en) 2024-04-01
JP7374992B2 (ja) 2023-11-07
HRP20221162T1 (hr) 2022-11-25
DK3840734T3 (da) 2022-09-26
PT3840734T (pt) 2022-09-19
JP2022503581A (ja) 2022-01-12
EP3840734A1 (de) 2021-06-30
PL3840734T3 (pl) 2022-12-19
ES2927000T3 (es) 2022-10-31
ZA202100512B (en) 2022-02-23
SI3840734T1 (sl) 2022-10-28
RS63628B1 (sr) 2022-10-31
EP3840734B1 (de) 2022-07-20
IL279825A (en) 2021-03-01
US11173121B2 (en) 2021-11-16
WO2020039017A1 (de) 2020-02-27
IL279825B1 (en) 2023-12-01
HUE060169T2 (hu) 2023-02-28

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